ePRO Systems Validation: Clearly Defining the Roles of Clinical Trial Teams and ePRO System Providers
نویسندگان
چکیده
منابع مشابه
ePRO systems validation: clearly defining the roles of clinical trial teams and ePRO system providers.
The emergence of technologies that enable the direct electronic capture of patient-reported outcome (PRO) data has been a profoundly significant innovation in PRO endpoint assessment in clinical trials. Based on evidence that has been mounting over the past 20 years, paper-based self-reports of measurements (e.g., peak flow values) and experiences or sensations (e.g., symptoms) are far from opt...
متن کاملValidation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force.
Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label cl...
متن کاملconstruction and validation of the translation teacher competency test and the scale of students’ perceptions of translation teachers
the major purpose of this study was to develop the translation teacher competency test (ttct) and examine its construct and predictive validity. the present study was conducted in two phases: a qualitative phase as well as a quantitative phase. in the first phase of the study, the author attempted to find out the major areas of competency required for an academic translation teacher. the second...
Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials
Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient's perspective. As a result, there is growing emphasis on well defined and reliable PRO measures. In addition, advances in technology have signific...
متن کاملErratum to: Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials
With regard to the following sentence in the ‘Disclosures’ section: ‘‘During the preparation of this manuscript, Ms. Eremenco, Mr. O’Donohoe, Ms. O’Gorman, and Mr. Malizia were employed by companies that provide ePRO systems and/or ePRO consulting services for sponsors of clinical trials.’’ It should have been specified that William Malizia was employed by Medidata Solutions during the preparat...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Value in Health
سال: 2013
ISSN: 1098-3015
DOI: 10.1016/j.jval.2013.04.006